Two-in-one Covered and Uncovered Metal Stent

  • STATUS
    Recruiting
  • End date
    Dec 31, 2021
  • participants needed
    100
  • sponsor
    Ajou University School of Medicine
Updated on 31 July 2021
reflux
obstruction
metastasis
biliary obstruction

Summary

Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency. To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced. In the current study, the investigators aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.

Description

Endoscopic placement of a self-expandable metal stent (SEMS) is the principle method for palliation of inoperable malignant distal biliary obstruction. As the survival time for those patients has improved due mainly in part to development of chemotherapeutic intervention, it is becoming important to prevent recurrent cholangitis and liver failure by prolonging the SEMS patency, leading to continuation of chemotherapy and better prognosis. Therefore, one-time stent insertion before disease-progression-related death is an ultimate goal of developing an ideal biliary stent.

SEMSs have been found to be superior to plastic stents in terms of the stent patency, because it prevent accumulation of biliary sludge owing to larger diameter. The ideal designs of biliary SEMSs for prolongation of the stent patency include 1) bare metal mesh for tissue embedding to prevent stent migration, 2) covering material to counteract neoplastic tumor ingrowth, and 3) anti-reflux structure to reduce enteric biliary reflux. However, none of bare, covered, and anti-reflux metal stent alone constantly demonstrated superiority over the others in the stent patency.

To compensate for the limitations of each stent, a double stent system in which both covered and bare SEMSs are integrated into one stent system was introduced in the field of the interventional radiology, but further data accumulation is needed to assess the comparability with various conventional SEMS types in terms of stent patency, reintervention efficacy, and clinical outcomes following reintervention, because in this system two metal stents are implanted at once exclusively via percutaneous route and clogged inner covered stent cannot be removed at the time of the reintervention. Recently a new covered and uncovered SEMS in which the clogged inner stent can be endoscopically removed leaving the outer stent in place, was introduced. In the current study, we aimed to evaluate the efficacy and safety of this stent in patients with inoperable malignant distal biliary obstruction.

Details
Condition Pancreatic Cancer, Pancreatic disorder, Biliary neoplasm, Neoplasm of unspecified nature of digestive system, Malignant neoplasm of gallbladder, Gallbladder Disease, Pancreatic Disorders, Extrahepatic Bile Duct Cancer, Gallbladder Carcinoma, Lymph Node Metastasis, Lymph Node Metastases, Urothelial Tract Cancer, Islet Ce417ll Cancer, Gall Bladder Disorders, Gall Bladder Cancer, Biliary Tract Cancer, Digestive System Neoplasms, gallbladder cancer, cancer of the pancreas, pancreatic cancers, cancer, pancreatic
Treatment Two-in-one stent
Clinical Study IdentifierNCT04337333
SponsorAjou University School of Medicine
Last Modified on31 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Malignant biliary obstruction, 2 cm distal to the hilum Not eligible for
curative surgical resection owing to metastasis, locally advanced stage, or
high operation risk Eastern Cooperative Oncology Group Performance status 0-3

Exclusion Criteria

Being evaluated for potential benign biliary stricture or possible operation
History of biliary surgery except cholecystectomy Coagulopathy (International
normalized ratio >1.5, platelet count <50,000) Coexist other organ dysfunction
(American Society of Anesthesiologist physical status grade III or IV)
Inability to obtain informed consent
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